500 mg film-coated tablets
mycophenolate mofetil
What Mycophenolate mofetil Accord is and what it is used for
Immunosuppressive agent.
Mycophenolate mofetil Accord is used to prevent the body from rejecting a transplanted kidney, heart, or liver. Mycophenolate mofetil is used with other medicines such as cyclosporine and corticosteroids.
Mycophenolate mofetil contained in the Mycophenolate mofetil Accord may also be authorized for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you take Mycophenolate mofetil Accord
WARNING
Mycophenolate causes birth defects and miscarriages. If you are a woman and could become pregnant, you must show a negative pregnancy test before starting treatment and you must follow the doctor’s instructions on contraception.
Your doctor will talk to you and give you written information, especially about the effects mycophenolate has on the fetus. Read the information carefully and follow the instructions.
If you do not fully understand the instructions, ask your doctor to explain them again before taking mycophenolate. See further information in this section under “Warnings and precautions” and “Pregnancy and breastfeeding”.
Do not take Mycophenolate mofetil Accord
- if you are allergic to mycophenolate mofetil, mycophenolate acid or any of the other ingredients of this medicine (listed in section 6).
- if you are a woman and may become pregnant and have not taken a negative pregnancy test before receiving your first prescription, as mycophenolate causes birth defects and miscarriages.
- if you are pregnant, planning to become pregnant or think you may be pregnant.
- if you are not using effective contraception (see Pregnancy, contraception and breastfeeding).
- if you are breast-feeding.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking the Mycophenolate mofetil Accord.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before starting treatment with Mycophenolate mofetil Accord.
Tell your doctor immediately
- if you experience signs of infection (eg fever, sore throat), unexpected bruising and / or bleeding.
- if you have or have had any digestive problems, e.g. stomach ulcer .
- if you are planning to become pregnant or if you become pregnant while you or your partner are using Mycophenolate mofetil Accord.
- if you have a rare hereditary deficiency of the enzyme a hypoxanthine – guanine -phosphoribosyl- transferase (HGPRT), such as Lesch-Nyhans and Kelley-Seegmiller syndrome.
If any of the above apply to you (or you are not sure), talk to your doctor immediately before starting treatment with Mycophenolate mofetil Accord.
Effect of sunlight
Mycophenolate mofetil Accord reduces the body’s defenses. A consequence of this is an increased risk of skin cancer. Limit the amount of sun and UV light you are exposed to. Do this by:
- Wear protective clothing that also covers your head, neck, arms and legs
- use a sunscreen with a high protection factor.
Children and und Omar
Children aged 2 to 18 years :
Mycophenolate mofetil Accord is used by children and adolescents (ages 2-18 years) to prevent the body from rejecting transplanted kidneys.
Mycophenolate mofetil Accord should not be used in children and adolescents (age 2-18 years) for heart or liver transplantation.
Mycophenolate mofetil Accord should not be used by children under 2 years of age.
Other medicines and Mycophenolate mofetil Accord
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes over-the-counter medicines, such as herbal medicines. This is because Mycophenolate mofetil Accord can affect the way some other medicines work. Other medicines may also affect the way Mycophenolate mofetil Accord works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines before starting Mycophenolate mofetil Accord:
- azathioprine or other drugs that reduce the activity of your immune system – given after a transplant.
- cholestyramine – used in the treatment of high cholesterol .
- rifampicin – antibiotics used to prevent and treat infections such as tuberculosis (TB).
- antacids or proton pump inhibitors – used for problems with acid in the stomach such as digestive problems.
- phosphate-binding drug – used by people with chronic kidney failure to reduce the amount of phosphate in the blood.
- antibiotics – used to treat bacterial infections.
- isavuconazole – used to treat fungal infections.
- telmisartan – used to treat high blood pressure .
- aciclovir, valaciclovir and ganciclovir.
Vaccines:
If you need to be vaccinated (with live vaccines) while taking Mycophenolate mofetil Accord, talk to your doctor or pharmacist first. Your doctor must advise you on which vaccines you can get.
You must not donate blood during treatment with Mycophenolate mofetil Accord and for at least 6 weeks after stopping treatment. Men should not donate semen during treatment with Mycophenolate mofetil Accord and for at least 90 days after stopping treatment.
Mycophenolate mofetil Accord with food and drink
Consumption of food and drink does not affect treatment with Mycophenolate mofetil Accord.
Pregnancy, contraception and breastfeeding
Use of contraceptives in women taking Mycophenolate mofetil Accord
If you are a woman and could become pregnant, you must use an effective method of contraception with Mycophenolate mofetil Accord. It includes:
- before you start taking Mycophenolate mofetil Accord
- throughout treatment with Mycophenolate mofetil Accord
- for 6 weeks after stopping treatment with Mycophenolate mofetil Accord.
Talk to your doctor about the most suitable contraceptives for you. It depends on your situation. Two forms of contraception are preferred as it reduces the risk of accidental pregnancy. Contact your doctor immediately if you think your contraceptive has not worked or if you have forgotten to take your birth control pills.
Women who meet any of the following criteria cannot become pregnant:
- you have passed menopause , ie turned at least 50 years old and your last menstrual period was more than a year ago (if your menstrual period has stopped due to treatment for cancer, there is a chance that you may become pregnant)
- your fallopian tubes and both ovaries have been removed (bilateral salpingo -oophorectomy )
- your uterus has had surgery ( hysterectomy )
- your ovaries have stopped working (premature menopause determined by a gynecologist)
- you have been born with any of the following conditions that are rare and lead to the inability to conceive: XY genotype, Turner syndrome or congenital absence of uterus
- you are a child or teenager who has not yet had your period.
Use of contraceptives in men taking Mycophenolate mofetil Accord
Available data do not indicate an increased risk of birth defects or miscarriage if the father takes mycophenolate. However, the risk can not be completely ruled out. As a precautionary measure, it is recommended that you or your female partner use reliable contraception during treatment and for 90 days after stopping Mycophenolate mofetil Accord.
If you are planning to have a baby, talk to your doctor about the potential risks and alternative treatments.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will talk to you about the risks of pregnancy and what options you can take to prevent your transplanted organ from being rejected if:
- you are planning to get pregnant
- you have skipped or think you have skipped a period, if you have unusual menstrual bleeding or if you think you are pregnant
- you have intercourse without using an effective method of contraception.
If you become pregnant during treatment with mycophenolate, you must inform your doctor immediately. However, continue to take Mycophenolate mofetil Accord until you see him or her.
Pregnancy
Mycophenolate causes a very high frequency of miscarriages (50%) and severe birth defects (23‑27%) in the unborn baby. Fetal injuries that have been reported include malformations of the ears, eyes, face (cleft lip/palate), malformations of the development of the fingers, heart, esophagus (the tube that connects the pharynx to the stomach), the kidneys, and the nervous system (eg [spinal cord hernia) that the vertebrae in the spine are not properly developed]). Your child may have one or more of these birth defects.
If you are a woman and could become pregnant, you must perform a negative pregnancy test before starting treatment and you must follow your doctor’s instructions on contraception. Your doctor may require more than one test to make sure you are not pregnant before starting treatment.
Breast-feeding
Do not take Mycophenolate mofetil Accord if you are breastfeeding. This is because small amounts of the drug can pass into breast milk.
Driving and using machines
Mycophenolate mofetil Accord has a moderate effect on your ability to drive or use tools or machines. If you feel drowsy, numb, or confused, talk to your doctor or nurse and do not drive or use any tools or machines until you feel better.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Mycophenolate mofetil Accord contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per unit dose, ie essentially ‘ sodium-free. is next to “sodium-free”.
How to take Mycophenolate mofetil Accord
Always take Mycophenolate mofetil Accord exactly as your doctor has told you.
Ask your doctor or pharmacist if you are unsure.
How much to take
The amount you should take depends on the type of transplant you have received. The usual dose is shown below. Treatment should continue for as long as you need to prevent rejection of the transplanted organ.
N herb transplant
Adults
- The first dose is given within 3 days after transplantation.
- The daily dose is 4 tablets (2 g of the medicine) taken as 2 separate doses .
- Take 2 tablets in the morning and 2 tablets in the evening.
Children (2 to 18 years)
- The dose one is given may vary depending on the size of the child
- The doctor will determine the most appropriate dose based on the child’s height and weight (body area – measured as square meters or “m 2 “).
The recommended dose is 600 mg / m 2 twice daily.
Heart transplant
Adults
- The first dose is given within 5 days after transplantation.
- The daily dose is 6 tablets (3 g of the medicine) taken as 2 separate doses .
- Take 3 tablets in the morning and 3 tablets in the evening.
Children
- There is no information on the use of Mycophenolate mofetil Accord in children with a heart transplant.
Liver transplantation
Adults
- You will receive the first dose of Oral Mycophenolate mofetil Accord no earlier than 4 days after the transplant and when you are able to swallow the medicine.
- The daily dose is 6 tablets (3 g of the medicine) taken as 2 separate doses .
- Take 3 tablets in the morning and 3 tablets in the evening.
Children
- There is no information on the use of Mycophenolate mofetil Accord in children with a liver transplant.
Method of administration
Swallow tablets whole along with a glass of water. You must not split or crush them.
If you take more Mycophenolate mofetil Accord than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Remember to bring the pack and tablets you have left with you.
If you forget to take Mycophenolate mofetil Accord
If you forget to take this medicine at any time, take your dose as soon as you remember. Then continue to take your dose at the usual times. Do not take a double dose to make up for a forgotten dose.
If you stop taking Mycophenolate mofetil Accord
The risk of rejection of the transplanted organ may increase if your treatment with Mycophenolate mofetil Accord is stopped. Do not stop taking your medicine unless your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell a doctor immediately if you notice any of the following serious
side effects ar – you may need urgent medical treatment:
- you have signs of infection such as fever or sore throat
- you get unexpected bruising or bleeding
- you get a rash, swelling of the face, lips, tongue or throat and difficulty breathing – you may have had a severe allergic reaction to the medicine (such as anaphylaxis , angioedema ).
Common side effects are
Some of the most common side effects are diarrhea, fewer white or red blood cells, infection, and vomiting. Your doctor will regularly take blood samples to check for changes in:
- the number of blood cells or signs of infection .
Children may get some side effects more easily than adults. It includes diarrhea, infection, decrease in the number of white and red blood cells.
Fight your infection
Mycophenolate mofetil reduces your body’s defenses. This prevents you from rejecting the graft. As a result, your body will not be as good at fighting infection as it used to be. This means that you can get more infections than normal. It includes infection in your brain, skin, mouth, stomach, intestines, lungs, and urinary tract.
Cancer of the lymph nodes and skin
As may occur in patients taking this type of medicine (immunosuppressive agents), a very small number of mycophenolate mofetil patients have developed cancer of the lymph tissue and skin.
General adverse effects
You can get general side effects that affect your entire body. It includes severe allergic reactions (such as anaphylaxis, angioedema ), fever, feeling very tired, sleep disturbances, pain (such as in the stomach, chest, joints, and muscles), headaches, flu symptoms, and swelling.
Other side effects may include:
Skin side effects such as:
- acne , cold sores, shingles , skin growth, hair loss, rash, itching .
Urinary tract side effects such as:
- blood in urine.
Side effects are in the gastrointestinal tract and mouth such as :
- swelling of the gums and cold sores,
- inflammation of the pancreas, colon or stomach,
- intestinal diseases including bleeding,
- liver disease,
- diarrhea, constipation, nausea, indigestion, loss of appetite, gas tension.
Side effects are in the central and peripheral nervous system such as :
- feeling of dizziness, drowsiness or numbness
- tremors, muscle twitching, seizures
- feeling anxious or depressed, changes in mood or thinking.
Side effects in the heart and blood vessels such as :
- altered blood pressure , increasing heart rate, dilation of blood vessels.
Lung side effects such as:
- pneumonia , tracheitis ,
- shortness of breath, cough which may be due to bronchiectasis (a condition in which the airways are abnormally dilated) or pulmonary fibrosis (scarring of the lungs). Tell your doctor if you develop persistent cough or shortness of breath,
- fluid in the lungs or chest cavity,
- problems with the sinuses.
Other side effects are such as:
- weight loss, gout , high blood sugar, bleeding, bruising.
How to store Mycophenolate mofetil Accord
- Do not store above 25 ° C. Store in the outer carton. Sensitive to light.
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton (EXP). The expiration date is the last day of the specified month.
- The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is 500 mg mycophenolate mofetil.
- Other ingredients are:
Tablet core: microcrystalline cellulose, povidone, hydroxypropyl cellulose, croscarmellose sodium, purified talc, magnesium stearate.
Tablet cover: hypromellose 6 cps, titanium dioxide (E171), macrogol 400, red iron oxide (E172), indigo carmine aluminum pigment (E132), black iron oxide (E172), purified talc
What the medicine looks like and contents of the pack
Mycophenolate mofetil accords are purple, capsule-shaped, biconvex, film-coated tablets imprinted with ‘AHI’ on one side and ‘500’ on the other.
Mycophenolate mofetil Accord is packaged in blister cards of 50, 150, and 250 tablets respectively.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 VK Utrecht
Netherlands
Manufacturer
Accord Healthcare BV
Winthontlaan 200
3526 kV Utrecht
Netherlands
Accord Healthcare Limited
Sage House
319, Pinner Road
North Harrow
Middlesex HA1 4HF
UK
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland